Blood administering apparatus



C. W. WALTER BLOOD ADMINISTERING APPARATUS RE A577/ W W W z ww,

W a *W a .I w w Oct. 17, 1961 c. w. WALTER BLOOD ADMINISTERING APPARATUS Filed March 29, 1954 2 Sheets-Sheet 2 United States Patent 'O .3,0o4,536 4 I .BL'ooD AmnNIsrEaiNG ArPARA'rUs Carl W. Walter,' 91 Highland `St Holliston,`MaSs. Filed Mar. 29, 1954, Ser. NO. '419,497 9 lClairns. l'(Cl. 1284-214) Thisinvention srelates to the handling and'administering of 'blood and more particularly to an improved apparatus and method for the sterile, hermetic sealed, clotfree infusion of whole blood. Theinventioniprovides a compact, unitary, lightWeig'ht, `flexible, all plastic apparatus which lends itself to a simple,'sure an'd bacteriologically safe'technique with minimum .chance of contamination and without danger of air embolism.

.'Ihe invention will be better understood from fa'conside'ration of the following description taken in conjunc tion with the accompanying drawing in which:

FIG. l'shows a recipient set according to the inven'tion;

FIG. '2.is a larger scale view of the'combinationifilter drip'chamber of.FIG. 1;

.-FIG. 3 shows a modified-form of the .inventiona'pparatus;

fFIG. 4zs a view partly in section 'and at right :angles to *FIG. 3; and

'FIG. :5 is alarger scalezsectio'nal-viewothe filter .of E163.

l:Primary objectivesjn the administration or-.infusion oflhuman whole blood to'apatient or-'afrecpient Vare the filtering, detecting and regulating vof the bloodffiow; the exhaustion and exclusion of air from 'the administering systemprior to and during zinfusion `and the ;provision fafluid 'channel which .is chemically inert,,hemo-repel- 'Ient, land sealed against contamination from .any.source. "he'apparatus and method of this inventionare uniquely adapted to these requirements.

.This application .is a continuationin part of my-copending application, Serial .No. .174,891, .filed .July 420, .1950, now Patent No. 2,702,034.

Referring now-more particularly to .FIGS. l and '2, one form of my novel recipient set is there shownto comprise the fiuid or blood conducting assembly andincorporated theren a combination .filter and drip column or chamber 20. In accordance with the invention the blood conductng assembly 10, the filterand drip Chamber 20, and the blood contacting elements comprised theren arefashioned of a flexible, lightweight plastic of the polyvinyl chloride group having suitable strength and toughness and being imperrneable, sterilizable, .heat -sealablc and also inert and hemo-repellent.

The blood conducting assembly .10 comprises more particularly a-length 11 of .tlexible plastic tubing of, say, 3 mm. lumen and `0.5 mm. wall gauge, and of a relatvely short length. The outer or -free end of the .tubing 11 is seized over the hub 12a of a coupling needle 12 such as the vpreferred illustrated doublecone'form asin said parent .application or as already known to .the art. The other end of the tube 11 is integrally connected at one end 22 of -the combination filter -and drip Chamber 20. 'At the other end 23 is-insta1led a length '13 of tubingappropriate to infusing purposes, say, 3 `to 4 feet. The outer or free end of the tubing 13 lis seized over the hub 14a of a phlebotomy or infusing needle 14, such as shown and described in my co-pendingapplication above mentioned.

`Further in iaccordance with the invention, the com binationfilter drip column or charnber V20 comprises a sleeve `or short length of larger diameter plastic -tubing 21, collapsed and heat sealed at its ends '22, 23. .The fusion-.of the said ends 22., 23 is seen to be accomplished with the ends of the tubes 11, 13 already installed. As in .said parent application the relatively larger tubing 21=of the chamber element 20 is similar in composition to Patented Oct. 17, 1961 2 that of the sm'aller tubing'l'l, E13 'and'in forming`the`flatseal end :closures 22, 23 the wall'of thetlarger tubing 'is brought together 'upon itsel'f 'and faround the `lumen-pr`e- 'sentin'g -smallertubing ilengths 11, "13 under'e'xternally :applied compression.

fIn the chaniber'rZO-'definedin an'd byetheilar'gerdiameter plastic tubing '21, :and "somewhat `'nearer 'the o utlet end in'the example'of FIGS. Z1 and 2 is installefd afi1ter screen, which may 'comprise =a 'nylon -b`olti`n`g 'cloth '221, `FIG. l2,- conveniently 'of '10'0 ;mesh and istretched *tat across an inner supporting hoop `2'5,-'a`nd 'clamped'jcircumfer'entially'under 'a concentri-'closefit'ting outer Hoop 25. The hoop's`25, 26 ;a're 'of 'tsu'bstanti'al 'rig'idity affd preferably'areformed-of'mlded nylon.

For -sterilepreservation -;pr`or`-`to=use the pointed ends of the piercing c'ouplerneedle {1'2 *and'of 'the 'firifusi'n'g nee'dle 14of'the -recipient s'et=m'a'y"-be inserted :ntoltlre 'opposite ends 'of -a s'hort Zlength JIS-of'the 'described flexible tubing, which'ends are-'seen 'to :be forced up 'over and seized to 'the 'cannlamounting ihubsof the `respec- Itivefneedles. The tube '15*may'fbe'nicked-at some intermediate point, as at 15a, topermit iescapego'fair steam during 'steriliztiom I'n V*placing the apparatu'sin Te'adyfi'forus'e condition, the recipient-'set is sterilized'inany-'convenient manner, and fiigenerallyYbythe application ofh'eat'of at`1eastf12`0` C. for a continuous period of thirty m'in'tites. Fur'tli'er,-'a 'non-we'tting, clotpreve'ritirtg for hemorep'ellenfifilm isprde- `lir'a'bly applie'd 't'of the `need1e 'c'annula's, z'and pyrogenlfree wte'rris 2rinsed y'thro'ug'htthef'nibin'g assenil lllf'aniifcou'- pIed 'needle's 12, 14.

;At the time of =an 1in'fn'simzl, zthe :eoup'ln'gf needle 112 withdrawn from the sheathing tube 15 an`d=applied=toe`a suitable `=source, which may 2b'e 'a flt'itible plasti'c "la'yflat .blood bag-*such as'thavdescr'ibed'in'm' "co-pending ;application The infusing inee'dle '14% "will `then`be 'applied 'to 'the reci'pient and fithe blood allowed ito flow, the 'rate being observe'd atithe 'dripchanibe'r 20. Thefflow m'ay be induced byigravityfiasfwhere the blood sourceiortsupply is'supp'orted bove=the level'of the =patient. Orithe infusio'n may -be'unde'r'squee'zng pressure 'or the Iike'a'pplied to the source of'sup'ply, or`blood bag.

Another and preferr'ed iform -'o"f the `'apparat'u's is illu`strated inlFIGS. B fto 5, and'there snown-'centrally'to-comprise a'cylindrical lee'v'efsimilarly formed 'of the "dslosed Synthetic plastic tubing fof'theexam'ples of vFIGS. '1 and 2 and fitted as a combination filterand drip'chaniber 50. This 'modified fcharnber '30 3is =formed more 'particularly of a"sleeve"fittened and'ffused'together "at`the ends or margins 31, '32, 'and also in A'an intermediate ;zone In other words, 'the 'opposite walls of the ends and the indicate'd intermediate '-portion -of the rtubing for sleeve are 'collapsed or brought together 'and =diele`ctriclly "or heatsealed to 'define lateral ban'd'seals or clos'ures 31,?3'2, 33,'which 'are seen to'be'convex, andftb'define the 'matimum sleeve width. The intermediate, partitioning sel or closure 33 is 'shown-'morel partic'til'a'rly to 'comprise duplicate oppose'd band sels '3311, 33'b. In accor'dance with thefinventi'on, the intermediate'sel 33 is`r'elati'vly c'losely spaced'to one end se'l T31,-'and'-p'rojects'laterlly at 'right -angles fthereto,lFIGS. 3 and 4. ""Fhu's the 'sleeve 30is 1forrned at one 'end'asfafrelatively small, .e.'short`er, relatively rigid drip '-h'amber 30a -and `at *the 'other a'sf'a relatively'large, `*i;'e.` longer, 'filte'r chamb'er 30h. 'Passag'e of '-the "blood lbetween "the *'filterfand "dri'p chambers `-Wb, 30a, is effected through a communicating tube 321, which mayhave a drip 'forniing A'projectio'n ''4a, FIG. '4.

'Further in 'accordan'ce withf'fthe inVen'iOn, filter chamber'llb mounts 'a 'filter'screen comprising ahemore'pllent nylon mesh sleeve inverted or folded 'back upon .itself to define a cylindricl, double-walled envelojp'e. .'Said envelope is contracted -andj'fused at .its open endand between its inner and outer wall 35a, 35h about the end of the collecting tube 41 projecting within the filter chamber 30h.

The preferred form of my novel recipient set is provided similarly as the embodiment of FIGS. l and 2 with means for coupling or connection to a blood source, supply'or container and for flowing the blood to the filter chamber 30b. Such connecting means may comprise a short, flexible, plastic inlet or collecting tube 41 integrally joined at one end to the sleeve end 32 and seized at the other end to the hub of a coupling needle 42. Alternatively, and tomnimize clotting of the blood, the inlet tube may be dspensed With, and the coupler itself received in the sleeve end.

A delivery or infusing tube 43 is coupled similarly as the collecting tube 41 at the other sleeve end 31 and to the drip chamber 30a. The plastic blood administering tube 43 may be of greater length than collecting tube 41, and may carry a phlebotomy needle of known construction. Or it may mount a coupler member 44, FIGS. 3, 4,'comprsing opposed hubs 44a, 44h tapering oppositely from an enlarged intermediate manipulating portion 448. The end of the tube 43 is seen to be seized over the one hub 44a and may be fixed thereon by a similarly tapering ferrule or clampng ring 45.

Further in accordance with the invention, the coupling and phlebotomy needles 42, 44, are sealingly encased in sheaths 46, 47, comprising short lengths of the plastic tubing fused at one end and seized at the other over the respective cannulas.

My novel recipient set in the improved embodiment of FIGS. 3 to 5 is sterilized similarly as the FIGS. 1 and 2 form prior to use and as facilitated by the venting men- 'tioned. It will be understood that both forms may be stored and transported sealed condition.

Considering now the simple, certain infusion technique of the invention in more detail, the inlet tube sheath is first withdrawn and the coupler 42 applied to a blood source as already` described. The filter chamber 30h is then squeezed and released to cstablish a half-way blood level in the same. The phlebotomy needle or adaptor sheath is next removed and the blood flowed through the tube 34, drip chamber 30a and delivery tube 43 to remove the air therefrom. It will be observed that no milking or thumping of the assembly is required. 'l'he phlebotomy needle or coupler 44 is then applied to the patient. The rate of flow may be observed at the drip forming projection 34a, and may be regulated as desired by control clip arranged to clamp the outlet tube 43. The flow of the blood may be induced by gravity or by pressure, as mentioned earlier. Additional infusion may be accomplished through a rubber sleeve 48, FIGS. 3 and 4, fittng snugly about a portion of the delivery tube 43. While both concentric sleeves are pierced for the introduction of the added solution, the system seal is preserved when the solution introducing needle is withdrawn by lthe resilient or elastic closing action of the rubber sleeve .incollapsed or folded, sterile- From the foregoing it will be appreciated that I have provided a fiexible, lightweight and durable apparatus for the sterile, hermetic-sealed administerng of human whole blood. The apparatus has been shown also to be 'hemo-repellent. to promote free and well-regulated flow, and to lend itself to a simple, certain and biologically safe administering technique, obviously applicablc as well to the handling of therapeutic fluids other than plasma and blood, as also disclosed in my prior co-pending application.

It will be understood that my invention, either as to means or method is not limited to the exemplary embodiments or steps herein illustrated or described, and I set forth its scope in my following claims.

I claim:

l. Therapeutic fluid conducting and infusing apparatus comprisng a fiexible impermeable hemorepellllt. tulg,

coupler and needle means at the opposite tube ends, a flexible impermeable hemorepellent sheath sealing said means, and normally sealcdapparatus-venting means on said sheath.

2. An integral recipient set for use in a blood and other therapeutic fluid handling system comprising an infusing tube, intermediate chamber-formng enlargement means in the tube, drip-forming and filter means arranged in said enlargement means, coupler and adapter needles mounted at the ends of said tube, and sheath-forming means received on said coupler and adapter needles and sealing said set.

3. A flexible conduit device for sterile administering of blood or other therapeutic fluid from a supply, comprising a tubing assembly including inlet and outlet lengths of flexible elastic transparent normally openlumen synthetic plastic tubing of a relatively small diameter selected as appropriate for therapeutic fluid conduct, a length of similarly constituted Synthetic plastic tubing of relatively larger dameter to present a hollow-chamber-formng enlargement in the tubing assembly between and flow-Wise spacing the inlet and outlet tubing lengths with the adjacent open-lumen ends of the latter extending into the respective ends of the enlargement, flat-sealed closures of the ends of said larger dameter tubing, said closures sealinely joined to the ends of said small tubing lengths with said ends embedded in and extendng through theml as ports into and from the hollow-chambered interior of the enlargement, and filter means and dro-forming means in the flow path in the enlargement, the distal ends of the inlet and outlet tubing lengths being adapted for counliug respectively to a fluid supply and to an infusing needle.

4. Apparatus for conducting and infusing blood or other therapeutic fluids from a supply, comprising a flexible imperable hemorepellent svnthetic plastic tube, the opposite tube end portions being of selected relatively small dameter adapted for coupler and needle connection, and linearly between said portions a transparent syn- I thetic plastic tubing member of larger dameter having flat sealed ends through which the proximate ends of the tube end portions extend as inlet and outlet ports.

5. Apparatus for conducting and infusing blood and other therapeutic fluids from a supply, comprising a flexble, imoermeable, hemorepellent, transparent Synthetic plastic tubing assembly including end tubings of relatively small dameter, an intermediate relatively larger chamberforming tubing member of the like composition and terminallv defined by flat-seals of the tubing wall material and having the adiacent ends of the end tubings extending openly through them, and means in said chamber-forming member providing a'drip-flow formation whereby the rate of the fluid flow through the apparatus may be detected.

6. Apparatus according to claim 5 including filter means in said chamber-forming tubing member.

7. Apparatus for administering whole blood or other therapeutic fluids from a supply, comprising a flexible delivery tube of Synthetic plastic composition, coupler and infusing means at the opposite ends of the tube, sheath means detachably sealing said coupler and ing means, the delivery tube including at a position between the coupler and a point snaced from the infusing means a length of flexible synthetic plastic tubing of larger dameter than the rest of said delivery tube so as to present a chamber-forming enlargement in and having its ends in sealed flow communication with preceding and` following portions of said tube, and drip-forrning and filter means in said enlarnement.

8. Apparatus for administering blood and therapeutic fluids from a supply, comprising a length of flexible elastic transparent tubing of irnpermeable inert hemorepellent plastic material presenting a filter-containing and dripflow-providing hollow chamber formation integrally formed of and by the tubing and terminally defined. by longitudinally spaced transverse flat seals of the tubing Wall, 'and chamber inlet and outlet means extending longitudinally through the seals.

9. Apparatus for administering therapeutic fluids from a supply, comprising a fluid flow conduit device formed of a |length of flexible elastic transparent thermoplastic tubing flattened and integrally fused at axially spaced transverse sealing zones each of which 'has a reduced longitudinal lport therethrough, the port of one sealing zone providing a fluid inlet to the device, the port of another sealing zone providing a flud outlet from the device, the tubing wall of the device providing between such sealing zones a. normally open tubular `Chamber formation presenting a viewable flow path therethrough, said transverse sealing zones being form'ed each in a plane extending substantially dametn'cally of the tubing and in determined orientation with respect to one another, and said chamber 'formation housing a drip-flow forming means in the flow path therein.

References Cited in the file of this patent UNITED STATES PATENTS 2,118,893 Meerbeck May 31, 1938 6 2,186,987 Nesset Jan. 16, 1940 2,322,7D1 Nesset et al. June 22, 1943 2,341,114 Novak Feb. 8, 1944 2,452,643 Fields Nov. 2, 1948 2,452,644 Fields Nov. 2, 1948 2,461,558 Meagher Feb. 15, 1949 2,470,943 'Page May 24, 1949 2,653,606 Ryan Sept. 29, 1953 2,664,085 Ryan Dec. 29, 1953 2,702,034 Walter Feb. 15, 1955 2,704,544 Ryan Mar. 22, 1955 FOREIGN PATENTS 761,528 France Jan. 5, 1934 165,283 France Nov. 10, 1884 OTHER REFERENCES 20 Plastic Equipment, Surgery, Gynecology and Obstetrics,

vol. 94, June 1952, pp. 687-692. Library.)

(Copy in Scentific 

